Regulatory Affairs Specialist in Switzerland

28 Nov 2018
26 Dec 2018
Regulatory Affairs
Contract Type
Regulatory Affairs Data Analyst

For this role we are looking for a RA specialist with strong IT skills able to support the local franchise Regulatory team with the creation of an IT System documentation and other activities in conjunction with MDR compliance work.

Job Profile:
- Support RA Business Lead in development and creation of IT System documentation for new functionality related to Technical Documentation requirements under MDR.
- Perform User Acceptance Testing of newly implemented IT requirements as assigned.
- Provide regulatory support for Life Cycle Management projects as assigned.
- Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.
- Perform Regulatory Change assessments as assigned.
- Perform Labeling and Promotional Material Reviews as assigned.

Your Background:
- Experience in IT system documentation and database management (Product Lifecycle Management (PLM)).
- Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745).
- Understanding of requirements of current Council Directive 93/42/EEC.
- Previous experience at DePuy Synthes preferred.
- Comprehensive knowledge in the handling with and of data in PLM and ERP system, preferentially experience in Agile e6, ERP (SAP), Windchill.
- Experienced skills in MS Office (Excel, Word, Access) for data analyses and comparisons.
- Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.

Please quote reference QLS44043 in all correspondence.

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